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U.S. Department of Health and Human Services

Class 2 Device Recall Secura DR

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  Class 2 Device Recall Secura DR see related information
Date Initiated by Firm May 05, 2010
Date Posting Updated October 21, 2010
Recall Status1 Terminated 3 on March 15, 2012
Recall Number Z-0115-2011
Recall Event ID 55922
PMA Number P980016S114 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code LWS
Product Medtronic Secura DR, model D224DRG, and model D234DRG not available in the U.S.. Digital Dual chamber implantable cardioverter defibrillator (DDE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA.
The Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
Code Information PUG225403H, PUG225404H, PUG225405H, PUG225406H, PUG225407H, PUG225408H, PUG225409H, PUG225411H, PUG225412H, PUG225414H, PUG225415H, PUG225417H, PUG225418H, PUG225419H, PUG225420H, PUG225421H, PUG225422H, PUG225423H, PUG225424H, PUG225425H, PUG225426H, PUG225427H, PUG225428H, PUG225429H, PUG225430H, PUG225431H, PUG225432H, PUG225433H, PUG225435H thru PUG225470H, PUG225472H thru PUG225502H, PUG225504H thru PUG225935H, PUG225937H thru PUG225949H, PUG225951H thru PUG225995H, PUG225997H thru PUG226022H, PUG226024H thru PUG226225H, PUG226227H thru PUG226253H, PUG226255H thru PUG226763H, PUG226765H thru PUG226794H, PUG226796H thru PUG226875H, PUG226877H thru PUG226896H, PUG226898H thru PUG226966H, PUG226968H, PUG226969H, PUG226970H, PUG226971H, PUG226972H, PUG226973H, PUG226974H, PUG226975H, PUG226976H, PUG226978H thru PUG227013H, PUG227015H, PUG227016H, PUG227017H, PUG227018H, PUG227019H, PUG227020H, PUG227021H, PUG227022H, PUG227023H, PUG227024H, PUG227026H thru PUG227077H, PUG227079H, PUG227081H thru PUG227121H, PUG227123H thru PUG227134H, PUG227136H, PUG227137H, PUG227138H, PUG227139H, PUG227140H, PUG227141H, PUG227142H, PUG227143H, PUG227144H, PUG227146H thru PUG227546H, PUG227548H thru PUG227582H, PUG227584H, thru PUG227685H, PUG227686H, PUG227687H, PUG227688H, PUG227690H thru PUG227738H, PUG227740H thru PUG227782H, PUG227784H thru PUG227824H, PUG227826H thru PUG228037H, PUG228039H, PUG228040H, PUG228041H, PUG228042H, PUG228043H, PUG228044H, PUG228046H, PUG228047H, PUG228048H, PUG228049H, PUG228050H, PUG228051H, PUG228052H, PUG228053H, PUG228054H, PUG228055H, PUG228056H, PUG228057H, PUG228059H thru PUG228129H, PUG228131H thru PUG228150H, PUG228152H thru PUG228235H, PUG228238H thru PUG228281H, PUG228283H thru PUG228296H, PUG228298H thru PUG228358H, PUG228360H thru PUG228386H, PUG228391H, PUG228392H, PUG228396H thru PUG228432H, PUG228438H, PUG228439H, PUG228440H, PUG228442H thru PUG228485H, PUG228487H thru PUG228598H, PUG228600H thru PUG228713H, PUG228716H thru PUG228762H, PUG228764H thru PUG228807H, PUG228809H thru PUG228940H, PUG228942H, PUG228943H, PUG228944H, PUG228946H thru PUG228973H, PUG228976H, PUG228977H, PUG228978H, PUG228979H, PUG228980H, PUG228981H, PUG228982H, PUG228983H, PUG228984H, PUG228985H, PUG228986H, PUG228988H thru PUG229052H, PUG229054H thru PUG229099H, PUG229101H, PUG229103H thru PUG229228H, PUG229230H thru PUG229307H, PUG229309H, PUG229310H, PUG229311H, PUG229313H thru PUG229373H, PUG229375H thru, PUG229444H, PUG229447H, PUG229448H, PUG229449H, PUG229451H thru PUG229488H, PUG229490H, PUG229491H, PUG229492H, PUG600002S, PUG600003S, PUG600017S thru PUG600069S, PUG600071S thru PUG600423S, PUG600425S, PUG600427S thru PUG600664S.

Model D234DRG, serial numbers: PZC200002H, PZC200003H, PZC200004H, PZC200005H, PZC200006H, PZC600074S thru PZC600084S, PZC600091S, PZC600092S, PZC600093S, PZC600131S thru PZC600146S, PZC600148S, PZC600149S, PZC600150S, PZC600151S, PZC600154S thru PZC600178S, PZC600181S thru PZC600209S, PZC600212S, PZC600213S, PZC600214S, PZC600215S, PZC600216S, PZC600217S, PZC600219S, PZC600221S, PZC600222S, PZC600224S, PZC600225S, PZC600227S, PZC600228S, PZC600229S, PZC600231S, PZC600236S, PZC600238S, PZC600239S, PZC600242S, PZC600244S, PZC600246S, PZC600251S, PZC600253S, PZC600256S, PZC600257S, PZC600259S, PZC600262S, PZC600263S, PZC600264S, PZC600267S, PZC600270S, PZC600272S, PZC600273S, PZC600274S, PZC600275S, PZC600276S, PZC600278S, PZC600280S, PZC600281S, PZC600283S, PZC600285S thru PZC600300S, PZC600302S, PZC600303S, PZC600304S, PZC600305S, PZC600308S, PZC600309S, PZC600312S, PZC600316S, PZC600318S, PZC600321S, PZC600322S, PZC600323S, PZC600325S, PZC600329S, PZC600330S, PZC600331S, PZC600332S, PZC600333S, PZC600335S, PZC600336S thru PZC600347S, PZC600349S thru PZC600361S, PZC600363S, PZC600364S, PZC600365S, PZC600366S, PZC600367S, PZC600368S, PZC600370S thru PZC600380S, PZC600383S, PZC600384S, PZC600385S, PZC600386S, PZC600388S, PZC600389S, PZC600392S, PZC600394S, PZC600396S, PZC600397S, PZ
Recalling Firm/
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact
Manufacturer Reason
for Recall
Medtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. In the u
FDA Determined
Cause 2
Software design
Action Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected. For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
Quantity in Commerce 41848
Distribution Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT